Q. Why are clinical trials important?
A. We all expect (or at least hope) that researchers will find new and better treatments and vaccines to prevent and cure the serious diseases of mankind. These new therapies are tested in volunteers through clinical trials to ensure that they are safe and effective. Q. How can I be sure it’s safe to participate in a clinical trial?
A. Some people are concerned that the study may be unsafe or dangerous or that they won’t be allowed to leave the study if they don’t like it. The Federal Government has strict rules and regulations that all government and drug company researchers must follow to protect participants in clinical trials. These rules require that participants are clearly informed of the risks involved in the trial and they must agree, in writing, to be included in the trial.
The rules require that, before a study can begin, it must be approved by a group of experts called an Institutional Review Board in the medical school, agency or hospital conducting the trial. In addition, all studies must monitor the data collected and the safety of the trial participants and report them to the regulatory agencies. This process ensures that the risks of trial participants are reduced as much as possible and that the information collected is accurate. In rare cases, a trial may be stopped early, either because the participants are being exposed to too much risk, or because the trial has already answered the questions it was designed to explore. Q. What are some steps to help me with my decision to participate?
A. Clinical trials are very important tools to develop new treatments and vaccines. To decide if clinical trial participation is right for you, you should consider the following:
1. Get the facts about the study: What is being studied? What are the possible risks? How often will you visit the clinic? What lab tests are needed? What costs, if any, will you have to pay? Do not agree to be in a clinical study if you know that you do not have the time to comply with it.
2. Know your rights and your responsibilities: You have the right to decline to participate in a clinical study. You have the right to leave the study anytime after you have begun. You have a right to keep your existing medical care.
Learn more about clinical trials at ClinicalTrials.gov